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GSK bags FDA approval for severe asthma drug Nucala

Drug to be launched as soon as possible

GlaxoSmithKline's first-in-class interleukin-5 (IL-5) inhibitor has been approved in the US, its first market, and will be launched 'as soon as possible', according to the firm.

The FDA has approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older who have a history of severe, breakthrough asthma attacks.

The license is broader than expected, as an FDA advisory committee had previously recommended that the drug be approved in adults only and not adolescents and consensus analysts' forecasts are for peak sales of around $600m, although some say the drug has $1bn-plus potential.

The once-monthly injectable drug - given by subcutaneous injection into the upper arm, thigh or abdomen - will be used as an add-on maintenance therapy for severe cases of eosinophilic asthma, a form which accounts for around a third of all cases.

Nucala is the first IL-5 inhibitor to be approved anywhere in the world, with GSK getting a green light ahead of rivals such as AstraZeneca's benralizumab - currently in phase III trials - and Teva's reslizumab which is due for regulatory filings early next year.

The FDA approval comes on the back of three placebo‑controlled trials in patients with severe asthma on currently available therapies. Compared with placebo, patients on Nucala had fewer exacerbations requiring hospitalisation and/or emergency department visits, and a longer time to the first exacerbation, according to the FDA.

Moreover, the agency notes that patients with severe asthma receiving Nucala were able to reduce their daily maintenance dose of oral corticosteroids, without sacrificing symptoms control. Treatment with GSK's drug did not however result in a significant improvement in lung function.

"Severe asthma is a debilitating condition in which patients are at high risk of frequent and serious asthma attacks," said Professor Ian Pavord of the University of Oxford, who was lead investigator in one of GSK's phase III Nucala trials.

"Half of all severe asthma patients have at least one urgent care visit per year," he added.

Roche and Novartis already sell a biologic drug for severe asthma - Xolair (omalizumab) - although this is approved for a different form of allergic asthma in which immunoglobulin E activation is a key driver of symptoms, as well as chronic hives. Between the two companies, sales of Xolair are around $1.5bn.

Nucala could also see competition in the future from Regeneron/Sanofi's IL-4 and IL-13 blocker dupilumab and AZ's anti-IL-13 antibody tralokinumab, which are also being developed for severe asthma.

Article by
Phil Taylor

6th November 2015

From: Regulatory



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